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U.S. Department of Health and Human Services

Class 2 Device Recall Orthopediatrics IM Femoral Nail

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  Class 2 Device Recall Orthopediatrics IM Femoral Nail see related information
Date Initiated by Firm July 21, 2009
Date Posted May 12, 2010
Recall Status1 Terminated 3 on October 25, 2010
Recall Number Z-0344-2010
Recall Event ID 52852
510(K)Number K083726  
Product Classification Nail - Product Code HSB
Product Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-026.

The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity.
Code Information Lots 105428 and 105429.
Recalling Firm/
Manufacturer		 Orthopediatrics Corp
210 N Buffalo St
Warsaw IN 46580-2730
For Additional Information Contact
574-268-6379
Manufacturer Reason
for Recall		 The potential exists for the nails to fracture during insertion of the nail.
FDA Determined
Cause 2		 Device Design
Action Distributor consignees were notified by email dated July 28, 2009 and requested to return the recalled products and instrument sets. If there are questions regarding this issue, please contact Gary Barnett at 574-268-6379.
Quantity in Commerce 23 of all products
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = ORTHOPEDIATRICS, CORP.
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